POLYETHYLENE GLYCOL, UNSPECIFIED

FDA Drug Profile — Polyethylene Glycol 3350 Powder for Solution

Drug Details

Generic Name
POLYETHYLENE GLYCOL, UNSPECIFIED
Brand Names
Polyethylene Glycol 3350 Powder for Solution
Application Number
ANDA203928
Sponsor
VALLEY MEDICAL PRODUCTS, LLC
NDC Codes
1
Dosage Forms
POWDER, FOR SOLUTION
Routes
TOPICAL
Active Ingredients
POLYETHYLENE GLYCOL 3350

Indications and Usage

Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Warnings

Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.